Researching Predicate Devices for Your 510(k)
By Leslie Oberhaus & Marlene Bobka
You’re developing an infrared thermometer and you’re not
even sure how it’s classified by FDA. How can you determine
the classification and predicates, see the disclosable portions
of earlier 510(k)s, examine user manuals, identify review
difficulties and see the Substantial Equivalence letters,
including the dates of 510(k) submission and decision?
The answers to these questions aren’t on FDA’s website, but
FDA’s files of 510(k) submissions hold all of this information
and more -- and much of this documentation is disclosable
under the Freedom of Information Act (FOIA).
The problem? A request using FOIA to obtain a predicate
510(k) can take up to 3 years to be answered – and you can’t
wait that long for the information you need to get your
medical device to market.
The solution? Go to www.foiservices.com and begin at the search box in the center of the page.
Enter a somewhat generic name for your product, in this example, “infrared thermometer”
Then click the search button to see a list of device titles which include the phrase
“infrared thermometer” somewhere in the descriptive record.
Here’s the result of your search:
Double-click on any record(s) you find of potential interest for a complete
document description. Result is on the next page.
Beyond 510(k)s: Researching Other Types of FDA Documents
You can use the same technique to search for many
other types of unpublished FDA documents. For
example, to find Establishment Inspection Reports
for a firm enter:
“Firm Name” EIR
in the search box (the double quotes are used to
specify a particular phrase).
You can even search on a name – for example, an
FDA investigator can be searched by entering:
“John Doe”
to locate all records including that phrase. Then you
can use the resulting documents to help you learn
more about a particular FDA investigator’s patterns,
habits, and interaction style.
Document Types
For more information about other kinds of
documentation, click on any of the document types
under the Click to Search box on the home page.
Entering Searches
For information about entering special terms such
as dates, phrases, FDA submission numbers, etc.,
click Search Hints on the menu across the top of the
home page.
Personalized Help
We are always happy to help you research a topic or
structure a search. For help with your topic, please
email [email protected] at any time, or phone
+1-301-975-9400 during our operating hours of
9:00am – 5:00pm ET, Monday-Friday.
The document details will help you determine if the full file will be helpful to you:
Document Title, Page Count & Price
Date of Substantial Equivalence Determination
FDA Device Number & Classification Code
Submission Type (Traditional, Special, Abbreviated)
FDA Classification Description
Predicate Devices
Device Class & 21 CFR Citation Describing the Device Code
Submission Date – Compare this with Date of Substantial Equivalence Determination Above
Company Name & Address
Persons Involved with the Submission
Contents of this Document
All of the information up to this point has been free. If
you want the complete document, add it to your shopping
cart, check out and the document can be immediately
downloaded in PDF format – no waiting for FDA to respond
to your FOIA request.
Need More Help in Finding
FDA Documents?
While we don’t have every FDA document ever
prepared, our collection is very extensive. If you need
more information, give us a call or send us an email; our
information specialists are always happy to help you.
This process offers you important benefits, including:
1) easy access to the most complete 510(k)
documentation available to help you identify
predicates, learn about competitors’ products and
their 510(k) experiences, and help develop your
own 510(k)
2) the ability to download files instantly rather than
potentially wait years for a government response,
and
3) maintaining the confidentiality of your research
interests - if you place requests with FDA your
queries are a matter of public record.
FOI Services, Inc.
704 Quince Orchard Road • Suite 275
Gaithersburg MD 20878-1770 USA
Phone: 1-800-654-1147 or +1-301-975-9400
Fax: 301-975-0702
Email: [email protected]
www.foiservices.com